DV Domain for Protocol Deviations in FDA Study Data
FDA’s June 2026 guide explicitly calls for the DV domain in submissions containing protocol-deviation data and identifies review-oriented variables beyond CDISC-required fields.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
FDA’s June 2026 guide says the DV domain should be included for protocol-deviation data and identifies additional variables used to support review of deviation trends and Bioresearch Monitoring activities.
Key details
Core IssueFDA’s June 2026 guide explicitly calls for the DV domain in submissions containing protocol-deviation data and identifies review-oriented variables beyond CDISC-required fields.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
Submit protocol-deviation data in DV and include the additional variables identified by the current guide, alongside CDISC-required variables, when submitting DV data.
Purpose
Support regulatory review of protocol-deviation patterns and downstream inspection/site-selection workflows without substituting a prose-only deviation listing for structured study data.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
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